Method of simultaneously cleaning and whitening teeth

ABSTRACT

A tooth cleaning and whitening method applies a light transmitting oxidizing gel to the teeth, after which a hand-held LED light source with a light transmitting lens and a cup forming a chamber having an open end is moved over the teeth so that the cup distributes the gel while the teeth are exposed to light transmitted through the lens. This not only ensures intimate contact of the teeth with the gel, but also maintains a more or less constant spacing between the light source and the tooth surfaces for optimum results. A sealant is then applied to the gel-coated teeth, after which a dental prophylaxis is performed by cleaning and scaling the teeth at the gum line, gingival margins, and crevicular spaces while avoiding excessive disruption of the sealant composition. This simultaneous cleaning and whitening procedure reduces patient time at the dentist compared to separate cleaning and whitening procedures.

BACKGROUND OF THE INVENTION

As the connections between healthy teeth and gums, and general overallhealth, have become increasingly evident in the past 100 years, oralcare has become an important part of people's daily health maintenanceregimens. In the process, a healthy looking smile has becomerepresentative of one's level of personal grooming and even socialstatus, with straight, white and well shaped teeth being promoted inadvertising and by cosmetic dentists as an integral part of one'sself-image. Over the past 20 years, the availability of tooth whiteningproducts and services has exploded in the marketplace, ranging from lowpriced over-the-counter (OTC) self-applied trays, strips, pens,mouthwashes and toothpastes, to expensive professionally applied ormonitored products and procedures capable of effectively whitening teethin as little as 45 minutes. In general, professionally applied productsand services administered to a patient in a dental office or otherclinical setting are seen to achieve the best teeth whitening results inthe shortest amount of time. This is primarily due to the concentrationof active ingredient, usually hydrogen peroxide or a hydrogen peroxideprecursor, found in professionally applied whitening compositions. Suchhigh concentrations, typically above 15% hydrogen peroxide by weight andoften as high as 50% hydrogen peroxide by weight, can only be safelyadministered in a controlled setting where a professionally trainedindividual can isolate soft tissues from contact with these highlyoxidative compositions. Frequent monitoring of a patient's progressover, for instance, a one-hour period is also critical in maintaining ahigh degree of safety when working with such high hydrogen peroxideconcentrations. Optionally, light or heat energy may be applied inconjunction with these strong oxidizing compositions, in order toaccelerate the process beyond that which is possible using just thecompositions on their own. In general, these professionally-monitoredproducts and services applied in a dental office or clinic will bereferred to collectively as in-office or chairside whitening procedures.

Chairside whitening procedures are generally performed during a dentalappointment scheduled specifically for the purpose of whitening thepatient's teeth, or as an adjunct following a professional teethcleaning, formally known as a dental prophylaxis or “prophy”. When toothwhitening is conducted immediately following a prophy, the total amountof time that the patient must remain in a dental chair can often exceedtwo hours.

A professional tooth cleaning is recommended by the American DentalAssociation as a means to prevent gum disease. Gum disease, orperiodontitis, is the primary cause of tooth loss in adults over the ageof 40. Gum disease has also been linked to other health problems, suchas heart disease, osteoporosis, respiratory diseases, and other moreserious systemic diseases. According to the Center for Disease Controland Prevention, approximately 68% of adults in the United States have atleast one professional tooth cleaning annually (2008). There isspeculation as to the reasons why so many adults neglect the benefitsobtainable from regular tooth cleanings, ranging from lack of healthinsurance to the fear of dental procedures. Lack of patient knowledge isa problem that can be managed, however studies have shown that bettereducation of patients only leads to modest changes in behavior andattitudes towards preventative dentistry.

In general, a typical teeth cleaning dental appointment comprises thefollowing procedural steps:

-   (1) A dental hygienist or dental assistant may or may not take    x-rays of a patient's teeth.-   (2) The dental hygienist or dental assistant will generally take    between 15 and 60 minutes to work on the teeth and gums (the exact    time depending upon both the amount of accumulation present, as well    as the teeth cleaning method chosen), using a variety of tools,    including manual or ultrasonic scalers to remove the tartar and    plaque from the patient's teeth.-   (3) The hygienist will then floss between the teeth and generally    complete the cleaning procedure by polishing the front (buccal) and    back (lingual) surfaces of the teeth with an abrasive composition    known as a prophylaxis (“prophy”) paste. Tooth polishing leaves a    smooth tooth surface that is more resistant to the adhesion and    buildup of dental plaque between dental cleaning appointments.

Despite the apparent benefits of preventative teeth cleaning asdescribed above, nearly 80% of the population has some form of gumdisease ranging from early stage gingivitis to advanced periodontitis.Symptoms of gum disease may include one or more of the following:bleeding gums, halitosis (bad breath), bad taste in the mouth, toothsensitivity, sore gums, loose adult teeth, abscessed teeth or gumspulling away from the teeth, changes in the way the teeth fit togetheror dentures fitting poorly, exudates between the gums and teeth, soresin the mouth, and actual tooth loss. Such a high rate of chronic oracute gum disease indicates a low level of compliance when it comes toscheduling of a regular dental cleaning, and any means of increasingsuch compliance would clearly be beneficial to the patient's generaloral health.

BRIEF DESCRIPTION OF THE INVENTION

The inventive tooth cleaning and whitening method comprises novelcompositions and procedural steps that allow for the simultaneousperformance of a dental prophylaxis and tooth whitening procedure. Theprocedure involves steps performed at least partially in parallel orcontemporaneously with a typical dental prophylaxis procedure duringwhich a significant amount of plaque, tartar and acquired pellicle areremoved. In general, these steps may include, but are not limited to,chemical, mechanical and/or chemomechanical tooth surface conditioning,contact or impregnation of one or more teeth with a catalyst, contact orimpregnation of one or more teeth with an oxidizing agent, exposure ofone or more teeth to actinic energy comprising heat, light, sound,ultrasound, air or mechanical pressure (and combinations thereof), andcontact or impregnation of one or more teeth with a toothremineralizing, opacifying or pigmenting composition. Combinations ofthe above procedural steps have been developed that accomplishsignificant whitening of stained teeth in less than about 90 minuteswhen performed in conjunction with or during a dental prophylaxisprocedure.

The ability of the inventive compositions and methods to simultaneouslywhiten teeth in parallel with a dental cleaning procedure is highlydependent upon the ability of the oxidizing agent to penetrate intotooth enamel and dentin. Both tooth enamel and dentin are compositestructures comprising both organic and inorganic phases as well asinterstitial spaces that are occupied by fluid. These interstitialspaces can accommodate fluid movement, which is generally in an outwarddirection, in other words from the interior of the tooth towards theenamel surface. However, fluids and other materials in contact with theenamel surface can influence fluid movement through tooth enamel anddentin with concentration gradients and/or capillary action, as well asin conjunction with pressure, heat, light and other external physicalforces that can change the dynamic relationship between the tooth andthe fluid in contact with the tooth.

Mathematical models have been constructed to predict the ability offluids to penetrate into porous substrates. The Lucas-Washburn equationis one such method of developing a comparative “Penetration Coefficient”for various fluids, based on their viscosity, surface tension (with air)and contact angle (with a porous substrate). The model assumes that theporous solid is a bundle of open capillaries, so in other words thePenetration Coefficient is a comparative predictor of capillary flowrate. The Lucas-Washburn equation

$d^{2} = {\left( \frac{\gamma\;\cos\;\theta}{2\;\eta} \right){rt}}$predicts the distance (d) traveled by a liquid in a porous substrate,where the liquid has a surface tension (γ) with air, a contact angle (θ)with the porous substrate surface and a dynamic viscosity (η), and where(r) is the capillary pore radius and (t) is the penetration time. Thebracketed component of the Lucas-Washburn equation is the PenetrationCoefficient, expressed as centimeters per second

${PC} = \frac{\gamma\;\cos\;\theta}{2\;\eta}$

The Lucas-Washburn equation predicts that the higher the PC, the fastera liquid will penetrate into a given porous capillary substrate. Thismeans that, at least in theory, a high PC: can be achieved for liquidswith low viscosities, particularly for compositions also having a lowcontact angle (which is often, but not always, associated with a liquidhaving a low surface tension that will lead to efficient wetting of theporous substrate.

Penetration coefficients have been used recently to design improveddental materials, specifically sealants and low-viscosity compositesintended to arrest the progression of carious lesions (Paris, et al,Penetration Coefficients of Commercially Available and ExperimentalComposites Intended to Infiltrate Enamel Carious Lesions, DentalMaterials 23 (2007) 742-748). The authors show that low viscositymaterials with high Penetration Coefficients (>50 cm/s) are capable ofpenetrating enamel carious lesions better than materials with low PCs(see corresponding patent application US 2006/0264532).

Prior art tooth whitening compositions have generally been formulated tohave high viscosities for better retention in dental trays during thebleaching process, which prevents migration of the whitening compositionfrom the tray due to salivary dilution. Moderate to high viscositieshave also been the norm for chairside whitening procedures, in order toprevent the whitening composition from migrating away from the toothenamel surface. According to the Lucas-Washburn equation, moderate tohigh viscosity tooth whitening compositions (greater than about 100centipoise at 25 deg C.) will have low Penetration Coefficients and thusbe predicted to have restricted movement into the whitening target, thatis, the porous enamel substrate. It would thus be advantageous to designa tooth whitening carrier composition comprising an oxidizing agent witha low viscosity (<100 cps) and a high Penetration Coefficient (>50 cm/s)in order to achieve rapid penetration into tooth enamel and dentin.

Other factors affecting the ability of a liquid penetrant to infiltrateenamel and dentin are (1) surface charge effects (which is related to pHof the micro environment within the tooth, as well as the pH and counterion content of the liquid penetrant), (2) adhesion of the liquidpenetrant to the tooth surface (which is related to the surface tensionand wetting ability of the liquid penetrant), and (3) osmotic effects(which are related to the direction of diffusion of the interstitialfluid in the tooth structure in relation to the liquid penetrant incontact with the tooth). Under certain circumstances, tooth whiteningcomposition having viscosities in excess of 100 cps are contemplated,for instance when auxiliary means of increasing the penetration rate areavailable. For example, a tooth whitening composition with a viscositybetween 5,000 and 100,000 cps can be utilized if heat and/or lightand/or vibrational energy is used to increase the penetration rate ofthe composition into the tooth enamel structure.

In general, one aspect of the inventive simultaneous tooth cleaning andwhitening method comprises the following steps, preferably performed ina sequence of steps comprising:

-   -   applying an oxidizing composition to the surfaces of the teeth        to be whitened; and    -   performing a dental cleaning or hygiene procedure while the        oxidizing composition is in contact with the teeth to be        whitened.

In another aspect of the invention, a method for simultaneously cleaningand whitening teeth comprises the steps of:

-   -   applying a conditioning composition to the teeth surface;    -   applying an oxidizing composition to the teeth surface;    -   applying a sealant composition to the teeth surface;    -   cleaning the teeth surface;    -   polishing the teeth surface; and    -   removing the condition compositions from the teeth.

In yet another aspect of the invention, a method for simultaneouslycleaning and whitening teeth comprises the steps of:

-   -   applying a composition to the teeth surface, wherein said        composition is comprised of at least a fluid carrier, a tooth        conditioner, an oxidizing agent and a water-resistant polymer,    -   cleaning said teeth surface;    -   polishing said teeth surface; and    -   removing said composition.

There is typically an extensive amount of scraping, scaling, and othermodes of plaque and tartar removal performed during a dental cleaning orprophylaxis. During the cleaning procedure, the patient's mouth isusually open for an extended period of time during which excess salivamay accumulate in the oral cavity and come in contact with the toothsurfaces. Also, the patient is typically asked to rinse with water or amouthwash at various times during the cleaning procedure in order toclear debris (plaque, tartar, blood, saliva, etc) from the oral cavitythat accumulates from the cleaning process. It has been found that inorder to achieve a desirable (that is, a noticeable) level of toothwhitening during said dental cleaning or prophylaxis, it is advantageousto prevent moisture from saliva or external sources (such as the rinsingsolutions referred to above) from directly contacting the tooth surfacesthat have been previously contacted with the oxidizing composition. Bycreating a barrier between extraneous moisture and the oxidizingcomposition, said moisture is prevented or limited in its ability toremove, dilute, neutralize or otherwise decrease the effectiveness ofthe oxidizing composition during the cleaning procedure.

One means of limiting the contact of external moisture with theoxidizing composition is to utilize an oxidizing composition havinghydrophobic (“water-repelling”) properties when in contact with thetooth surface.

An alternative means of preventing moisture contamination of theoxidizing composition on the tooth surface is to cover the oxidizingcomposition with a film of water-insoluble or water-resistance material.Such materials may include, but are not limited to, polymer films andwater-resistant or water-insoluble fluids, gels, creams, waxes andsolids.

Yet another alternative means of preventing moisture contamination ofthe oxidizing composition on the tooth surface is to cover the oxidizingcomposition with a curable composition that can be converted from aliquid or gel into a higher viscosity liquid, gel or solid upon exposureto an external source of energy. Said external energy source may beelectromagnetic or light energy, sound or ultrasound energy, mechanicalor vibrational energy, electrical energy, or combinations thereof.

A preferred tooth cleaning and whitening method comprises the followingsteps

-   1) Placing a cheek and lip retraction means into the oral cavity of    a subject. Said means may include a cheek retractor and/or cotton    rolls placed in such a way as to prevent the soft tissue of the    inside of the lips and cheeks from coming into contact with the    tooth surfaces,-   2) Conditioning of the teeth surfaces to be whitened with a    conditioning agent or conditioning composition, using chemical,    mechanical, or chemo-mechanical means,-   3) Contacting the conditioned tooth surfaces with one or more    compositions comprising an oxidizing agent,-   4) Contacting the tooth surfaces with a water-resistant coating or    film-forming composition to protect the oxidizing agent from direct    contact with external moisture during the tooth cleaning process,-   5) Cleaning and scaling of subject's teeth in proximity to the gum    line, gingival margins and crevicular spaces while the compositions    of steps (3) and (4) above are in contact with the tooth surfaces,-   6) Polishing the teeth with prophylaxis or polishing paste following    completion of step (5),-   7) Optionally repeating steps (3) and (4), and-   8) Cleaning and rinsing all residual materials from tooth and gum    surfaces that were applied or produced during the performance of    steps (1) through (7).

Modifications to the above procedure are possible and are some casespreferable. For instance, the conditioning agent or conditioningcomposition may be combined with the oxidizing composition of step (3)in order to reduce the amount of time required to perform the combinedcleaning and whitening procedure. Also, water-resistant properties maybe imparted to the oxidizing composition of step (3) in order to obviatethe need for a separate step (4). Therefore, it is contemplated, but notrequired, that the compositions and/or agents of steps (2), (3) and (4)may be combined into a single composition (a) prior to packaging, (b)just prior to use, or (c) on the tooth surface during use. Optionally, atooth-desensitizing agent, such as potassium nitrate, may be appliedbefore, during, or after any of the steps outlined above. Suchtooth-desensitizing agent may be applied as a stand-alone formulation orcombined with the conditioning agent, oxidizing agent, water-resistantor film-forming composition, or any combination of these.

It is also contemplated within the scope of this invention to employlight energy and/or heat energy to accelerate the tooth whiteningprocess through various means such as increasing the rate of oxidizingcomposition penetration into enamel and dentin, increasing thesusceptibility of tooth stain chromogens to oxidation, and acceleratingthe oxidation process through advanced oxidation processes such as thephoto-Fenton reaction. An added benefit of employing light energy,particularly that in the blue region of the light spectrum(approximately 400-500 nanometers), during the inventive simultaneoustooth cleaning and whitening process, is observed by the attenuationand/or killing of periodontal pathogens within the light energy exposurefield. A particularly useful benefit to reducing the viability ofperiodontal pathogens prior to, during and/or after a tooth cleaning isthe reduction in risk associated with a lower bacterial burden during amoderately invasive procedure (tooth cleaning) that can sometimesinvolve bleeding. Reduction of the available numbers and types of oralpathogens during a tooth cleaning process may be of significant benefitto the subject's overall oral and whole body health, since theassociation between the presence of periodontal pathogens, such as theblack pigmented bacteria species Fusobacterium nucleatum andPorphyromonas gingivalis, and the incidence of systemic diseases (suchas heart disease) has been shown in recent years to be quite strong.Light energy employed in the initial steps of the present inventivemethod is seen to be most beneficial, since pathogen reduction prior tothe invasive cleaning process would occur. However, light energy appliedat any point in time during the cleaning and whitening process can be ofsignificant benefit to the patient's gingival and periodontal health.

Particularly useful is light energy having the followingcharacteristics: wavelengths of between 380 and 700 nanometers (nm),between 400 and 500 nm, and between 410 and 460 nm; and light intensity(measured at the target surface, for example the tooth or gum surfaces,in terms of power density) of between 100 and 5,000 milliwatts percentimeter squared (mW/cm²), between 100 and 2,000 mW/cm², between 500and 1,500 mW/cm², and between 100 and 300 mW/cm. Light sources such aslight emitting diodes (LEDs), quartz halogen bulbs, tungsten halogenbulbs, plasma arc bulbs, and xenon flash lamps, to name a few, arecontemplated to have utility in the present invention. Preferred lightsources are LEDs with emission peaks between 400 and 500 nanometers.

BRIEF DESCRIPTION OF THE DRAWING

The objects of the invention will be better understood from the detaileddescription of its preferred embodiments which follows below, when takenin conjunction with the accompanying drawings, in which like numeralsand letters refer to like features throughout. The following is a briefidentification of the drawing figures used in the accompanying detaileddescription.

FIG. 1 is a schematic depiction of an over molded lens that can beattached to a hand-held dental curing lamp for enhancing whitening inaccordance with one aspect of the present invention.

FIG. 2 is an isometric view of the over molded lens shown in FIG. 1.

Those skilled in the art will readily understand that the drawings insome instances may not be strictly to scale and that they may further beschematic in nature, but nevertheless will find them sufficient, whentaken with the detailed descriptions of preferred embodiments thatfollow, to make and use the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The compositions of the present invention are designed to provide a fastand effective means of whitening the teeth during the performance of adental cleaning or prophylaxis. Various combinations of toothconditioning compositions, oxidizing compositions and sealantcompositions are envisaged to have utility in the practice of theinventive method, and the properties of these individual compositionsmay be combined into a single composition for ease of use andapplication. Alternatively, a tooth conditioning function may becombined with an oxidizing function into a single composition. Anotheralternative is to combine a tooth sealing function with an oxidizingfunction to reduce the number of application steps.

The tooth conditioning composition may comprise a fluid carrier and oneor more tooth conditioning ingredients. Fluid carriers include water,ethanol, diethyl ether, methoxypropane (methyl propyl ether), dimethylisosorbide and combinations thereof. The tooth conditioning function,that is the ingredient or ingredients that remove the acquired pellicleand subsequently open the enamel porosities for better penetration ofthe oxidizing composition, may be provided by ingredients having anacidic and/or calcium chelating capabilities. Useful acidic compoundsinclude both inorganic and organic acids such as phosphoric acid,hydrochloric acid, acetic acid, lactic acid, citric acid, and theirsalts. Useful calcium chelating compounds include both inorganic andorganic chelating agents such as ethylenediaminetetraacetic acid (EDTA),phytic acid, 1-hydroxyethylidene-1,1′-diphosphonic acid, citric acid,and their salts. The tooth conditioning composition may also comprise acolorants and/or pigments to assist in the placement and application ofthe tooth conditioning composition onto the teeth during the combinationwhitening and cleaning procedure.

The oxidizing composition comprises a fluid carrier and an oxidizingagent. Fluid carriers include water, ethanol, diethyl ether,methoxypropane (methyl propyl ether), dimethyl isosorbide andcombinations thereof. Oxidizing agents include peroxides, metalchlorites, percarbonates, perborates, peroxyacids, hypochlorites andcombinations thereof. Preferred oxidizing agents are hydrogen peroxide,carbamide peroxide, poly (vinyl pyrrolidone)-hydrogen peroxide complex(Peroxydone, ISP Corp, Wayne, N.J.), peroxyacetic acid, and sodiumchlorite. The oxidizing composition preferably has a viscosity of lessthan about 100 centipoise and most preferably less than about 10centipoise. The oxidizing composition may also comprise activecomponents further related to the tooth whitening function (such asstabilizers, a secondary oxidizing agent, an oxidation catalyst, apH-adjusting agent, and a calcium chelating agent), or to a non-toothwhitening function (such as remineralization of the tooth surface,prevention of tooth decay, tooth-desensitization, prevention ofgingivitis and/or periodontal disease, and other diseases or conditionsof the oral cavity). In addition, the oxidizing composition may compriseone or more colorants and/or pigments to assist in the placement andapplication of the sealant onto the teeth during the combinationwhitening and cleaning procedure. Such colorants and/or pigments mayalso be present to provide a stain masking effect that changes theappearance of the tooth while the oxidizing composition is in contactwith the tooth surface during the procedure.

Preferred oxidation catalysts are chelated metal complexes, inparticular complexes of iron and manganese. Particularly preferredchelated metal complexes are the family of tetraamido-N-macrocyclicligand (TAML) iron catalysts described in U.S. Pat. Nos. 7,060,818,6,241,779, 6,136,223, 6,100,394, 6,054,580, 6,099,586, 6,051,704,6,011,152, 5,876,625, 5,853,428, and 5,847,120.

The oxidizing compositions of the present invention may also contain asurface active agent in order to lower the surface tension of thecomposition to provide for better wetting and adhesion of the liquid tothe surface of the tooth. Anionic, cationic, non-ionic and zwitterionicsurfactants are contemplated to have utility in providing the oxidizingcompositions with a low surface tension. Preferred surfactants aresulfobetaines (such as amidosulfobetaine 3-16 and Lonzaine CS) andfluorosurfactants (such as Capstone 50 and Capstone FS-10).

Sealant compositions of the present invention may comprise awater-resistant polymer, copolymer or crosspolymer, and a fluid carrier.Hereinafter the term “polymer” and “polymers” shall be used to denotepolymer(s), copolymer(s) or crosspolymer(s). Suitable water-resistantpolymers include acrylate polymers, methacrylate polymers, modifiedcellulosic polymers, silicone polymers, urethane polymers, polyamidepolymers, vinyl polymers, vinyl pyrrolidone polymers, maleic acid oritaconic acid polymers, and others. The water-resistant polymer shouldbe soluble or dispersible in the fluid carrier. Particularly preferredpolymers are poly (butylmethacrylate-co-(2-dimethylaminoethyl)methacrylate-co-methylmethacrylate), poly (ethyl acrylate-co-methylmethacrylate-co-trimethylammonioethyl methacrylate chloride),ethylcellulose, and esterified or crosslinked poly (methyl vinylether-co-maleic anhydride). The fluid carrier may be a volatile solventwhich will evaporate after contacting the sealant composition with thetooth surface, leaving behind a liquid or solid coating or film. Saidsolvent should have an evaporation rate equal to or greater than that ofwater, and preferably equal to or greater than that of butyl acetate.Suitable solvents include, but are not limited to, water, ethanol,diethyl ether, methoxypropane (methyl propyl ether), acetone, ethylacetate, and other highly volatile solvents.

Alternatively, the sealant compositions may be curable liquids or gels,which are placed on the tooth surface and subsequently exposed to someform of activating energy which converts the liquid or gel sealantcomposition to a solid coating or film. Curable sealant compositions mayalso be chemically cured, whereby two or more components are combinedjust prior to use and placed on the tooth surface to cure, in otherwords, to change from a liquid or gel into a solid coating or film.

The sealant composition may also comprise active components related to atooth whitening function (such as an oxidizing agent, an oxidationcatalyst, a pH-adjusting agent, and a calcium chelating agent), or to anon-tooth whitening function (such as remineralization of the toothsurface, tooth-desensitization, prevention of tooth decay, prevention ofgingivitis and/or periodontal disease, and other diseases or conditionsof the oral cavity). In addition, the sealant composition may compriseone or more colorants and/or pigments to assist in the placement andapplication of the sealant onto the teeth during the combinationwhitening and cleaning procedure. Such colorants and/or pigments mayalso be present to provide a stain masking effect that changes theappearance of the tooth while the sealant composition is attached to thetooth surface in the form of a coating or film.

The combination whitening and cleaning method described herein may alsobe practiced by employing an additional source of energy to acceleratethe oxidation process and further reduce the time needed to complete theprocedure. External energy sources such as electromagnetic or lightenergy, sound or ultrasound energy, mechanical or vibrational energy,electrical energy, or combinations thereof may be advantageouslyemployed at any point in time during the combination whitening andcleaning procedure to accelerate the process.

EXAMPLES

In order to achieve a significant degree of tooth whitening in anabbreviated time frame suitable for integration into the tooth cleaning(dental prophylaxis) process, ideal conditions for (1) oxidizerpenetration into the tooth and (2) conversion of initial oxidizer forminto active whitening species must be facilitated.

Time limitations are imposed on the additional steps required to achievewhitening during the tooth cleaning process by the realities of patientscheduling in the typical dental office, and such additional stepsshould not exceed 30 minutes beyond or in addition to the time requiredto perform a typical dental prophylaxis. Optimal conditions forpenetration of an active whitening composition into tooth enamel must bepresent in order to reduce the amount of time and oxidizer concentrationrequired to reach intrinsic stain depth. Important factors related tooxidizer penetration into the tooth are (1) the viscosity of theoxidizing composition, (2) the surface tension of the oxidizingcomposition and (3) the surface free energy (also called the criticalsurface tension) of the tooth surface.

The surface free energy of exposed tooth enamel is generally in therange of about 50-55 dynes/cm, however the acquired pellicle can lowerthis number significantly. In fact, one of the important functions ofthe acquired pellicle is to reduce the critical surface tension of thetooth surface in order to reduce the adhesion of bacteria. Liquid andgel compositions contacting the tooth surface penetrate into the toothstructure in relation to four primary factors: time, viscosity of theliquid or gel, surface tension of the liquid or gel, and surface freeenergy of the tooth at the point of contact.

The relationship of liquid surface tension to solid surface free energy,low contact angle (the tangential angle formed by a droplet deposited ona solid surface) and low viscosity, are all directly related to thePenetration Coefficient (as derived from the Lucas-Washburn equation)and must be optimized for the whitening composition to (1) rapidly wetthe surface of tooth enamel and (2) penetrate the available porositiesand channels through enamel as quickly as physically possible.

Example 1

The ability of various oxidizing compositions to penetrate intact enameland dentin was determined as follows. Extracted molar and pre-molarteeth were obtained from orthodontists with patient consent and storedrefrigerated in phosphate buffered saline (PBS) solution at pH 6.8 untiluse. In order to assess the ability of various liquid carrier fluids topenetrate tooth enamel, teeth were sectioned to remove their roots and a3 mm diameter chamber was created in the center of the sectioned crownthat was filled with PBS solution. The crowns were partially immersed(chamber with PBS solution facing up) in various liquid carrier fluidsand a small (1 microliter) sample of the PBS solution was drawn every 60seconds and place on a peroxide test strip (EM Quant Strips 10337, EMDChemicals, a division of Merck SA, Darmstadt, Germany) to determine theamount of time required for hydrogen peroxide to penetrate the toothenamel and dentin from the outer surface of the crown to the interiorchamber containing PBS.

Oxidizing compositions in Table 1 below were prepared and stored in 20ml glass vials until use.

TABLE 1 Percent (w/w) Ingredient 1A 1B 1C 1D 1E 1F 1G 1H 1I 1J 1K 1LWater 75.0 65.0 75.0 65.0   85.0 75.0 65.0 75.0 65.0 75.0 65.0 100.0Ethanol 200 10.0 20.0 5.0 15.0 5.0 15.0 Diethyl ether 5.0 5.0Methoxypropane 5.0 5.0 Acetone 10.0 20.0 Dimethyl isosorbide 10.0 20.0Hydrogen peroxide 15.0 15.0 15.0 15.0   15.0 15.0 15.0 15.0 15.0 15.015.0  0.0 Adjusted to pH 4.0 with potassium hydroxide 0.1M Viscosity(cps @ 25 C.) <1 <1 <1 <1    1.3 <1 <1 <1 <1 1.5 1.5  1 Surface tensiondynes/cm <40 <40 <40 <40 >50 <40 <40 <40 <40 <40 <40 >50 Contact angle(deg) <10 <10 <10 <10   30+ <10 <10 <10 <10 15 15  50+ PC(calculated) >100 >100 >100 >100 <50 >100 >100 >100 >100 >100 >100 <30H₂O₂ detection (min) 13 12 12 10   20 14 12 14 14 15 15 ND* *ND = Notdetected

Oxidizing compositions in Table 1 trended towards faster penetration ofthe tooth when both contact angle and viscosity of the composition waslow (Examples 1A, 1B, 1C, 1D, 1F, 1G, 1H, 1I, 1J, and 1K). Oxidizingwith high contact angles (greater than 30 degrees) did not seem topenetrate as well as those with contact angles less than about 10degrees.

Example 2

The following multi-step process was developed to provide for rapid andeffective whitening of the teeth during a dental cleaning procedure.

Step 1—Acquired Pellicle Removal

Facilitating oxidizer penetration into the tooth requires a thoroughremoval or modification of the acquired pellicle prior to contact withthe oxidizer formulation. Therefore, whether integrated into a dentalprophylaxis procedure or performed as a stand-alone process, the firststep in the abbreviated whitening process (after determining a startingtooth shade) must be the removal of the acquired pellicle usingchemical, mechanical or (preferably) chemo-mechanical means. Once theacquired pellicle has been removed, it is important that the “cleaned”tooth enamel surface has limited contact with the patient's saliva priorto application of the oxidizer composition (see Step 2) in order toprevent reformation of the pellicle film on the exposed enamel surface.Removal or modification of the acquired pellicle and optionalmicro-roughening of the exposed enamel surface will elevate the enamelsurface free energy (preferably above about 60 dyne/cm), which promotesbetter wetting of the enamel surface by the oxidizing composition.Surface wetting is a key factor related to the speed at which acomposition penetrates enamel, analogous to the effects of viscosity andsurface tension on the penetration of bonding adhesives into conditionedenamel and sealants into caries lesions.

Step 1a

Placement of cheek retractor or other means of preventing contact of thelips and interior gum surfaces with the teeth.

Step 1b

Application of Conditioner for 30-60 seconds

Tooth Conditioner Composition

Ingredient Percent (w/w) Water 90.0 Poly (methyl vinyl ether-co-maleicanhydride)* 10.0 *Gantrez S-95 (ISP Corp, Wayne, NJ) (hydrolyzed, pH2.0)

Step 2—Oxidizer Contact and Penetration

Once the acquired pellicle has been removed, the teeth surfaces arecontacted with a low viscosity oxidizer composition with a surfacetension significantly lower than that of the surface free energy of theexposed enamel surface. A low viscosity oxidizing composition that has alow surface tension will have a very low contact angle when placed onthe enamel surface and thus be better suited to penetrate into theenamel porosities. The oxidizer composition should comprise hydrogenperoxide in an aqueous form (or mixed with viscosity-reducing solvents)and at a concentration between about 1% and 30% by weight (higheramounts being contemplated in situations where precise control andplacement of the oxidizing composition is possible). The oxidizingcomposition should also have a pH within a range similar to thatreported for the isoelectric point of tooth enamel, which is betweenabout 3.8 and 4.7, although higher pH levels are possible with oxidizingcompositions comprising ionized species capable of counteracting theinfluence of charged components in tooth enamel. The oxidizingcomposition is brushed repeatedly onto the tooth surfaces to be whitenedover the period of about 7-10 minutes to provide as much full strengthhydrogen peroxide at the interface over the initial treatment phase.

Step 2a

Application of oxidizing composition to buccal and (optionally) lingualsurfaces of teeth

Oxidizer Composition

Example 1D Step 3—Sealing Enamel Surface Prior to Dental ProphylaxisProcedure

In order to prevent dilution or removal of the oxidizing composition inor from the tooth enamel treated in accordance with Step 2 above, awater-resistant protective sealant is applied (and if solvent-based,allowed sufficient time for the carrier solvent to evaporate). Thesealant composition may also comprise an additional oxidizing agent toprovide an additional reservoir of whitening active, and/or an advancedoxidation catalyst in order to promote active oxidizing species such ashydroxyl radicals (—OH) and perhydroxyl anions (—OOH), and/or adesensitizing agent to reduce or eliminate any tooth sensitivityassociated with the procedure.

Step 3a

Application of Sealant to buccal and (optionally) lingual surfaces ofteeth

Sealant Composition

Ingredient Percent (w/w) Ethanol 200 proof 90.0 Poly (butylmethacrylate-co-(2-dimethylaminoethyl) 10.0 methacrylate-co-methylmethacrylate)* *Eudragit E100 or EPO (Evonik Rohm GmbH, Darmstadt,Germany)

The sealant composition is applied onto the surfaces of the teethpreviously contacted with the oxidizing composition and allowed to fullydry before proceeding to Step 4.

Step 4—Performance of the Dental Prophylaxis Procedure

Following the sealing process, a dental prophylaxis is performed usingstandard protocols and materials. Care should be taken to avoidexcessive disruption of the sealant on the buccal and lingual (ifcoated) surfaces of the teeth during the cleaning procedure. The dentalprophylaxis is otherwise performed in a standard fashion, includingpolishing of the teeth with a standard prophy paste (which will removethe Sealant applied in Step 3). A final tooth shade may be taken at thistime.

Step 5—Final Treatment

If time permits, Steps 2 and 3 are repeated after prophy cleanup. Nofurther intervention is required to remove the Sealant if applied aftercompletion of the dental prophylaxis and dismissal of the patient. TheSealant may remain in place after the patient leaves the office and willslowly erode over time. The patient may also be supplied with a home-useversion of the oxidizing composition and the sealant as an option forcontinued improvement in tooth color.

The above steps were performed on extracted molars and premolars (n=25)obtained through orthodontists with patient consent and storedrefrigerated in phosphate buffered saline (PBS) solution at pH 6.8 untiluse. Individual teeth were removed from the PBS solution, allowed to airdry for 60 seconds and the roots inserted up to the cementoenameljunction into a high viscosity aqueous gel to keep the roots hydratedduring the procedure. An initial tooth shade was taken using a MinoltaCM504i chromameter (Konica-Minolta) and recorded. Steps 2 (totaltreatment time of 10 minutes) and 3 (total treatment time of 120seconds) were performed on the extracted teeth, and a 32 minute periodwas allowed to elapse during which the teeth were rinse with water every8 minutes to simulate the rinsing process that typically occurs duringthe cleaning process. After the simulated cleaning process time hadelapsed, the teeth were polished with a medium grit prophy paste using aslow speed handpiece and prophy cup. Teeth were rinse with water and afinal tooth shade was taken using the method described above andrecorded in Table 2 below (L, a, b=Initial color readings, L*, a*,b*=final color readings).

TABLE 2 Tooth L a b L* a* b* Delta L Delta a Delta b Delta E 1 76.103.14 15.98 78.11 1.61 13.13 2.01 −1.53 −2.85 3.81 2 76.90 3.44 12.4580.98 2.40 13.01 4.08 −1.04 0.56 4.25 3 74.23 3.32 16.05 78.33 1.9812.77 4.10 −1.34 −3.28 5.42 4 74.25 2.00 16.21 77.21 1.74 12.12 2.96−0.26 −4.09 5.06 5 78.21 3.24 14.76 80.43 1.99 11.26 2.22 −1.25 −3.504.33 6 75.21 3.01 15.90 77.77 2.45 14.01 2.56 −0.56 −1.89 3.23 7 74.791.82 13.88 78.23 1.43 13.20 3.44 −0.39 −0.68 3.53 8 72.24 3.32 16.4375.20 2.99 13.95 2.96 −0.33 −2.48 3.88 9 73.19 3.87 15.81 78.81 2.3310.32 5.62 −1.54 −5.49 8.01 10 77.31 3.66 14.73 77.60 1.84 9.99 0.29−1.82 −4.74 5.09 11 71.89 3.97 17.68 76.39 2.77 14.02 4.50 −1.20 −3.665.92 12 74.54 3.58 14.32 78.40 2.87 13.13 3.86 −0.71 −1.19 4.10 13 73.293.82 14.65 78.41 2.02 13.03 5.12 −1.80 −1.62 5.66 14 74.03 3.92 16.3376.75 2.36 14.56 2.72 −1.56 −1.77 3.60 15 71.99 2.98 15.03 77.90 1.7511.82 5.91 −1.23 −3.21 6.84 16 73.98 3.92 15.57 78.02 1.99 11.08 4.04−1.93 −4.49 6.34 17 73.12 3.22 16.23 76.19 1.56 13.84 3.07 −1.66 −2.394.23 18 76.00 3.42 15.48 78.88 1.98 10.63 2.88 −1.44 −4.85 5.82 19 73.943.73 14.14 78.58 2.02 10.73 4.64 −1.71 −3.41 6.01 20 74.74 3.46 15.0277.33 2.38 13.05 2.59 −1.08 −1.97 3.43 21 70.95 3.98 17.43 75.02 2.9712.83 4.07 −1.01 −4.60 6.22 22 73.49 4.03 16.55 77.91 3.13 13.43 4.42−0.90 −3.12 5.48 23 76.03 3.10 18.30 78.73 1.57 13.22 2.70 −1.53 −5.085.95 24 73.83 3.28 17.43 77.00 1.22 10.15 3.17 −2.06 −7.28 8.20 25 74.172.98 15.12 78.36 2.09 11.03 4.19 −0.89 −4.09 5.92 Average 73.84 3.4616.03 77.63 2.06 11.98 3.79 −1.40 −4.04 5.72

Example 3

The following whitening method was used to demonstrate the ability of ahigh viscosity tooth whitening composition to remove an artificial stainfrom the surface of a bovine enamel substrate in vitro when light energyis use to enhance penetration.

Staining of Bovine Enamel Slabs

1. Substrates

-   -   a. 10 mm×10 mm bovine incisor (enamel) fragments mounted in        clear resin    -   b. 600 grit finished surface    -   c. Unsealed        2. Storage of Substrates    -   a. Always store substrates at 100% relative humidity, or at        4° C. in Double Distilled H₂O or Phosphate Buffered Saline        solution    -   b. Never allow substrates to fully dry out as surface will        change, dry only as part of staining procedure and never for        extended periods.        3. Staining Solution    -   a. 3 g of fine ground leaf Tea    -   b. 3 g of fine ground Coffee    -   c. 300 ml of boiling ddH₂O    -   d. Infuse for 10 min with stirring (use magnetic stirrer)    -   e. Filter solution through tea strainer with additional filter        paper    -   f. Cool to 37° C.        4. Preparation of tooth samples    -   a. Labelling: Label the bovine samples on one side of the resin        with permanent marker (to track the samples if using more than        one)    -   b. Rub the surface of the enamel with wet wipe and then grit        finish is on the wet surface with orbital motion covering the        whole surface for nearly 10 sec    -   c. Wash the surface with water and make it dry with Kimwipe    -   d. Sealing: Seal all the surfaces of the resin, excluding the        enamel surface of bovine fragment (i.e., all four sides and        bottom) with clear nail varnish    -   e. Leave it on bench top for air drying with the enamel surface        touching the bottom for 30-45 min    -   f. Etching: sequential immersion in 0.2 m HCl saturated Na₂CO₃,        1% Phytic Acid (30 seconds each) and finally rinse with double        distilled H₂O    -   g. Make it dry with Kimwipe and then they are ready for staining        5. L*a*b Measurement    -   Measurement before and after staining.        6. Staining Procedure    -   a. Prepare the staining broth (Section 3) and fill a glass        bottle with 200 ml of the broth    -   b. Keep the samples to be stained in the broth continuously for        four days    -   c. Tighten the cap of the bottle to ensure that the broth is not        evaporating from the bottle    -   d. Gently mix the broth every day to make sure that the        particles are not settling at the bottom of the bottle    -   e. After staining the samples, rinse substrate with Millipore        water (wipe it) and measure LAB values

Samples of the stained bovine enamel slabs were contacted with a toothwhitening composition shown in Table 3.

TABLE 3 Ingredient Percent Deionized water 35.40 Glycerin 20.00Etidronic acid 0.30 Potassium stannate 0.10 Hydrogen peroxide 12.00Carbopol 974P-NF 2.00 Sucralose 0.30 PEG-60 hydrogenated castor oil 3.00Flavor 1.00 Ammonium Hydroxide 29% (to pH 5.0) 1.10 Total 100.00

The above composition is a transparent gel having a viscosity ofapproximately 10,000 cps @ 25 deg C. and a pH of 5.0.

The tooth whitening composition of Table 3 was brushed on to thesurfaces of stained bovine enamel slabs prepared as described above.Immediately after contacting the slabs with the tooth whiteningcomposition, light energy was applied using a hand-held dental curinglight with a high-powered LED emitting approximately 500 mW/cm₂ of bluelight with a peak wavelength of approximately 450 nm. The hand-heldcuring light used a lens cup 10 depicted schematically in FIGS. 1 and 2as having a lens 12 over which a thermoplastic elastomer cup 14 wasmolded to provide a mechanism for spacing the curing light energy L(represented notionally in FIG. 1) at the same distance from the surfaceof the bovine slab for each sample. The over molded cup forms a smallchamber that controls the positioning and movement of the gel on thetooth surface, while simultaneously emitting light energy through thelens onto the tooth surface to accelerate the penetration of the toothwhitening composition into the tooth structure.

The resulting changes in L, a and b values, together with the compositedelta E change in tooth color, is shown in Table 4 below.

TABLE 4 dL da db dE*ab tooth 1 8.15 −4.17 −6.17 11.04 tooth 2 6.91 −3.56−5.71 9.65 tooth 3 2.69 −1.76 −5.18 6.09 tooth 4 5.53 −2.89 −2.45 6.71

As can be seen by the changes in L, a and b values, as well as thecomposite delta E value changes, significant tooth color changes may beeffected by utilizing a high viscosity tooth whitening composition whencombined with a high intensity light source adapted with a lenscomprising an over molded thermoplastic elastomer spacer cup. It isanticipated that the inclusion of a light exposure step, as demonstratedin the Example, would be of significant advantage in improving the toothwhitening effect observed in Examples 1 and 2. Exposing the toothsurfaces and their surrounding soft tissue will also lead to animprovement in periodontal health through the reduction of periodontalpathogens such as black pigmented bacteria.

Summary

It will be understood that the embodiments of the invention describedabove can be modified in myriad ways other than those specificallydiscussed without departing from the scope of the invention. Generalvariations to these embodiments may include different tooth whiteningcompositions, light sources, methods of applying compositions and/orlight, and contact and/or exposure time of tooth whitening compositionsand/or light on the tooth surface.

Those skilled in the art will readily recognize that only selectedpreferred embodiments of the invention have been depicted and described,and it will be understood that various changes and modifications can bemade other than those specifically mentioned above without departingfrom the spirit and scope of the invention, which is defined solely bythe claims that follow.

What is claimed is:
 1. A method for performing an improved dentalprophylaxis procedure incorporating tooth whitening, the methodcomprising: applying a light transmitting oxidizing agent to one or moreteeth in an oral cavity to be cleaned and scaled during a dentalprophylaxis; obtaining a hand-held light source that projects lightenergy; exposing a tooth surface with the light transmitting oxidizingagent in place to light energy using the hand-held source; after theexposing step applying a sealant composition to the one or more teethwith the oxidizing agent in place, wherein the sealant composition willresist moisture contamination of the oxidizing agent; performing adental prophylaxis by cleaning and scaling teeth in the oral cavity,including the one or more teeth having the oxidizing agent and sealantcomposition in place, in proximity to at least one of as gum line,gingival margin, and crevicular space while avoiding excessivedisruption of the sealant composition; and removing the sealantcomposition by polishing teeth in the oral cavity after performing thedental prophylaxis step.
 2. The method of claim 1, wherein the step ofapplying the oxidizing agent is preformed prior to or during theexposing step.
 3. The method of claim 1, wherein the oxidizing agent hasa viscosity of at least 100 centipoise.
 4. The method of claim 3,wherein the oxidizing agent comprises a gel having a viscosity of atleast 5,000 centipoise.
 5. The method of claim 4, wherein the gel has aviscosity of about 10,000 centipoise.
 6. The method of claim 1, whereinthe light applied to the tooth surface has a wavelength between about380 and about 700 nanometers.
 7. The method of claim 1, wherein thelight applied to the tooth surface has a wavelength between about 400and about 500 nanometers.
 8. The method of claim 7, wherein the lightapplied to the tooth surface has a wavelength between about 410 andabout 460 nanometers.
 9. The method of claim 1, wherein the lightapplied to the tooth surface has an intensity between about 100 and5,000 milliwatts per square centimeter.
 10. The method of claim 9,wherein the light applied to the tooth surface has an intensity betweenabout 100 and 300 milliwatts per square centimeter.
 11. The method ofclaim 1, further comprising the step of applying a conditioningcomposition for removing acquired pellicle from teeth surfaces prior toapplying the oxidizing agent.
 12. The method of claim 1, wherein theoxidizing agent further comprises a conditioning agent fir removal ofacquired pellicle from teeth surfaces.
 13. The method of claim 1,wherein the sealant composition is converted to a more viscous form, bythe application of light energy.
 14. The method of claim 1, wherein theoxidizing agent is applied to more than one of the teeth to be cleanedand scaled during the dental prophylaxis step.
 15. The method of claim1, wherein the oxidizing agent has a viscosity of less than 100centipoise.
 16. The method of claim 1, wherein the oxidizing agent has aviscosity of less than 10 centipoise.
 17. The method of claim 1, whereinthe removing step is completed no more than 90 minutes after beginningthe step of applying the oxidizing agent.
 18. A method for performing animproved dental prophylaxis procedure incorporating tooth whitening, themethod comprising: applying a light transmitting oxidizing agent to oneor more teeth in an oral cavity to be cleaned and scaled during a dentalprophylaxis; obtaining a hand-held instrument with an elastomeric membercomprising a chamber having a distal end and a lens molded in place at aproximal end, wherein light is projected from a light-emitting diodethrough the lens and chamber; moving the hand-held instrument over atooth surface with the light transmitting oxidizing agent in place withthe distal end of the elastomeric member in contact with the toothsurface to expose the tooth surface to light energy projected throughthe lens and chamber; thereafter applying a sealant composition to theone or more teeth with the oxidizing agent in place, wherein the sealantcomposition will resist moisture contamination of the oxidizing agent;performing a dental prophylaxis by cleaning and scaling teeth in theoral cavity, including the one or more teeth having the oxidizing agentand sealant composition in place, in proximity to at least one of a gumline, gingival margin, and crevicular space while avoiding excessivedisruption of the sealant composition; and removing the sealantcomposition by polishing teeth in the oral cavity after performing thedental prophylaxis step.
 19. The method of claim 18, wherein theelastomeric member includes a cup with a continuous wall providing anenclosed chamber with an open distal end and the lens at a closedproximal end, and the steps of applying an oxidizing agent and exposingit to light energy are performed by moving the open distal end of thechamber over a tooth surface to distribute oxidizing agent in thechamber over the tooth surface while exposing the tooth surface to lightenergy projected through the lens and oxidizing agent in the chamber.20. The method of claim 19, wherein the oxidizing agent has a viscosityof at least 100 centipoise.
 21. The method of claim 20, wherein theoxidizing agent comprises a gel having a viscosity of at least 5,000centipoise.
 22. The method of claim 21, wherein the gel has a viscosityof about 10,000 centipoise.
 23. The method of claim 3, wherein oxidizingagent is applied prior to the exposing step.